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| EPA/OPPTS | RIN: 2070-AD61 | Publication ID: Fall 2008 |
| Title: Endocrine Disruptor Screening Program (EDSP); Policy and Procedures for Initial Screening | |
| Abstract: Section 408(p) of the Federal Food, Drug, and Cosmetic Act, as amended by the 1996 Food Quality Protection Act, directs EPA to establish and implement a program whereby industry will be required to screen and test all pesticide chemicals to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate. The requirements of section 408(p) were implemented through the creation of the Endocrine Disruptor Screening Program (EDSP) in 1998. The EDSP has the following three components that are proceeding simultaneously: 1) Developing and validating assays 2) Setting chemical testing priorities 3) Establishing FFDCA section 408(p) testing orders and related data procedures 1) DEVELOPING AND VALIDATING ASSAYS: Federal Advisory Committee Act committees have been providing advice to the EDSP on assay development and validation since the program's inception. On March 25-27, 2008, the FIFRA Science Advisory Panel (SAP) reviewed the proposed EDSP Tier 1 Screening Battery. The FIFRA SAP Report dated June 11, 2008, recommended using the Agencys proposed Tier 1 Screening Battery. The "final" EDSP Tier 1 Screening Battery will be published in the Federal Register before the issuance of testing orders. 2) SETTING CHEMICAL TESTING PRIORITIES: For chemical testing priorities, the approach to selecting the first 50-100 chemicals was finalized in September 2005 (70 FR 56449) and EPA implemented that approach. EPA published a draft list of 73 pesticide active ingredients and high production volume (HPV) pesticide inert chemicals for initial screening in June 2007 (72 FR 33486). The public comment period for the draft initial list ended on February 11, 2008. EPA is revising the list based on further review and the received public comments. A final initial list will be published in the Federal Register before issuance of testing orders. 3) ESTABLISHING FFDCA SECTION 408(P) TESTING ORDERS AND RELATED DATA PROCEDURES: EPA intends to commence Tier 1 screening of the first group of pesticide active ingredients by issuing test orders under FFDCA section 408(p) and FIFRA section 3(c)(2)(B) to entities identified as technical pesticide registrants. EPA intends to commence Tier 1 screening of the first group of pesticide inert ingredients by issuing test orders under FFDCA section 408(p) to entities identified as manufacturers/importers of the identified chemicals. EPA has developed draft implementation policies and procedures that describe the procedures that EPA will use to issue orders, the procedures that order recipients would use to respond to the order, how data protection and compensation will be addressed in the test orders, and other related procedures or policies. The draft policies and procedures for the initial EDSP testing was made available for public comment with Federal Register Notice published December 13, 2007 (72 FR 70842). The public comment period for the draft policies and procedures for the initial EDSP testing was extended once to March 12, 2008. EPA is revising the policies and procedures for the initial EDSP Tier 1 Screening based on further review and the received public comments. The revised policies and procedures for the initial EDSP Tier 1 Screening will be published in the Federal Register before issuance of testing orders. EPA is finishing the revisions to the initial list, the EDSP Tier 1 Screening Battery, and the EDSP Policies and Procedures as described above. EPA intends begin issuing test orders early in 2009. | |
| Agency: Environmental Protection Agency(EPA) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: None (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: 15 USC 2603 TSCA 21 USC 346(a) FFDCA 42 USC 300(a)(17) SDWA 7 USC 136 FIFRA | |
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Legal Deadline:
None |
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Timetable:
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| Additional Information: SAN No. 4728; EPA publication information: Notice; Draft Procedures - http://www.epa.gov/fedrgstr/EPA-TOX/2007/December/Day-13/t24166.pdf; EPA Docket information: EPA-HQ-OPPT-2007-1080 | |
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Information URL: http://www.epa.gov/scipoly/oscpendo/index.htm | |
| RIN Data Printed in the FR: No | |
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Agency Contact: William Wooge Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7203M, Washington, DC 20460 Phone:202 564-8476 Fax:202 564-8483 Email: wooge.william@epa.gov Gary Timm Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7203M, Washington, DC 20460 Phone:202 564-8474 Fax:202 564-8483 Email: timm.gary@epa.gov |
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